eligibility_summary
Adults ≥18, consented. Part 1: SCLC after ≥2 lines incl platinum (±PD‑L1), epNEC/LCNEC after ≥1 platinum, mixed tumors eligible if ≥50% NEC. Part 2: epNEC, DLL3‑high, after ≥1 platinum. ECOG 0–1, measurable disease (RECIST 1.1), archival FFPE tissue, adequate organs, prior toxicities resolved, contraception. Exclude active brain mets, leptomeningeal/epidural disease, ILD/pneumonitis, severe IO AEs, recent therapy/radiation, prior DLL3 TCE/cell therapy, immunodeficiency/immunosuppression.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05882058 (DAREON-5) tests BI 764532 (obrixtamig), an intravenous bispecific T‑cell engager (antibody‑like biologic) that binds DLL3 on tumor cells and CD3 on T cells. Mechanism: brings T cells into contact with DLL3+ cancer cells to activate CD3/TCR signaling, triggering cytotoxic granule release and cytokine-mediated killing. Targets: DLL3 (an atypical Notch pathway ligand aberrantly expressed in neuroendocrine malignancies) on tumor cells and CD3 on T cells. Indications: relapsed/refractory extensive-stage SCLC and other NECs (epNEC, LCNEC), Part 2 enrolls DLL3‑high epNEC. Goal: select a tolerable dose and assess tumor shrinkage.